FDA Drug recall D-0557-2024
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., T…
- FDA Drug
- Class II
- terminated
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., T… by Denison Pharmaceuticals, citing cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0557-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-28 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denison Pharmaceuticals |
| Distribution | n/a |
Product
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Reason
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Identifiers
| ndc | 63029-103-01 |
|---|---|
| ndc | 63029-103-02 |
| code_info | Lot #: 0855, Exp. 8/31/ 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0557-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.